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The last sentence says it all... Nic 57/15 On Thu, Sep 24, 2009 at 7:28 AM, mschild <[log in to unmask]> wrote: > It is worth reading to the very end > Maryse > > > > The drug, rasagiline (Azilect), was approved in 2006 by the U.S. Food and > Drug > Administration on the basis of studies showing that it reduced Parkinson's > symptoms such as trembling and slowed motion. The new study, reported in > the > Sept. 24 issue of the New England Journal of Medicine, was designed to > determine whether the drug also acts on the underlying nerve deterioration > that causes the disease. > > "In our heart, what we are hoping for is neuroprotection," said study > author > Dr. C. Warren Olanow, a professor of neurology and neuroscience at Mount > Sinai > School of Medicine, in New York City. > > To distinguish the effect on symptoms from the hoped-for effect on the > underlying disease, "we used a totally new study design, to see if it is > disease-modifying," Olanow explained. > > The study enlisted 1,176 people with previously untreated Parkinson's > disease > who were seen at medical centers around the world. At the start, half took > daily doses of either 1 milligram or 2 milligrams of rasagiline for 36 > weeks, > while the other half took a placebo. After that, all the participants took > either 1 milligram or 2 milligrams of rasagiline for another 36 weeks. > > A complex system to measure the treatment effects showed an apparent > improvement in the participants who took the 1-milligram doses but not in > those taking the 2-milligram doses. > > "It did something to affect the course of the disease," Olanow said. "We > don't > know why, but we are entitled to speculate." > > His speculation is based on a detailed study of the 25 percent of > participants > who showed the greatest benefit. "What I think is right is that the higher > dose > had a greater effect on symptoms than the lower dose, so that masked our > ability to detect its effect on disease progression," Olanow said. "We > thought > that this floor effect was why we couldn't see a difference." > > Olanow was enthusiastic about the results. "This doesn't prove > unequivocally > that it [rasagiline] is neuroprotective, but there is no other rational > explanation for the results," he said. "This is good news for Parkinson's > patients." > > Asked if he would prescribe the drug for that reason, Olanow said, "Yes, I > would personally prescribe it." > > A much more skeptical response came from Dr. William J. Weiner, chair of > neurology at the University of Maryland, who took part in the study. > > "The authors were very careful in the paper not to indicate that they had > shown neuroprotection," Weiner said. "The tone of the article itself is > moderate." > > The methods used to determine trial results need scrutiny, he said. "They > used > a lot of very fancy mathematical models, some of which had not been used > before," Weiner said. "Most neurologists wouldn't understand the > mathematical > models they used. Research neurologists don't deal with equations about the > slope of curves." > > And the end results were not impressive, he maintained. "The difference > reported in the study is less than two points on a scale that has 150 > points," > Weiner said. > > The reason why the lower dose worked, and the higher one didn't? "It simply > could be luck," he said. > > While rasagiline can provide benefits in reducing symptoms of early > Parkinson's > disease, Weiner said he was worried that "patients will be given what I > believe to be false hopes" by the new study. > > "It has mild symptomatic effects, but I do not prescribe this drug for > neuroprotection and this study doesn't convince me to do that," Weiner > said. > > Several of the study authors have received consulting or lecturing fees > from > pharmaceutical companies, including Teva, the maker of Azilect. > > > > http://health.usnews.com/articles/health/healthday/2009/09/23/new-parkinsons- > drug-draws-mixed-reviews.html<http://health.usnews.com/articles/health/healthday/2009/09/23/new-parkinsons-%0Adrug-draws-mixed-reviews.html> > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: mailto: > [log in to unmask] > In the body of the message put: signoff parkinsn > ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn